Associate Director, Regulatory Affairs
Core
Implement global regulatory strategies and develop CTA/IND submissions for biologics-based therapeutics, serving as the primary point of contact with regulatory authorities.
Role type
Associate Director, Regulatory Affairs
Builds
Innovative biologics-based therapeutics
Domain
Biotechnology / Pharmaceutical / Oncology / Immunology
Required skills
Regulatory strategy development, CTA/IND submission management, FDA/EMA/Health Canada agency interaction, Drug development lifecycle expertise (IND/CTA to NDA/BLA), Monoclonal antibody/biologics knowledge, GxP compliance, Cross-functional team leadership, Data analysis
Preferred skills
Biologics program support experience, External consultant/vendor management, International regulatory guidelines knowledge
Technologies
GxP, IND, CTA, NDA, BLA
Responsibilities
Develop and implement regulatory strategies for pipeline programs, Oversee regulatory submissions and ensure appropriate content, Serve as primary expert on regulatory matters and policy changes, Interact with regulatory agencies and oversee discussions, Oversee external regulatory consultants and vendors
Seniority
Senior, hands-on IC